The US FDA has approved Izervay (complement C5 inhibitor) for the treatment of GA secondary to AMD. The therapy is expected to be available in the US in 2-4wks.
The approval was based on the P-III trials (GATHER1 & 2) evaluating Izervay (2mg, qm, IVT) in 286 & 448 patients, which showed a significant reduction in the rate of GA progression over sham at 12mos. across two P-III clinical trials & slowed loss of photoreceptors and disease progression as early as 6mos. with ~35% reduction in 1yr. of treatment
Additionally, the most common adverse reactions (≥ 5%) were reported at 12mos. across the (GATHER) clinical trial program in patients who received Izervay (2mg)
Ref: PR Newswire | Image: Iveric Bio
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